HHS NEWS

U.S. Department of Health and Human Services

P98-13                      FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE       Print Media:         202-205-4144
April 21, 1998              
                            Consumer Inquiries:  800-532-4440

FDA PROPOSES NEW RULES TO INCREASE SAFETY OF FRUIT AND VEGETABLE JUICES

The first proposed regulation would require processors of packaged fruit and vegetable juices, both domestic and foreign, to implement hazard control programs at their plants to prevent microbiological, chemical and physical contamination of their products. Part of this proposal would require manufacturers of unpasteurized juices to adjust their processes to achieve a 100,000-fold reduction in the numbers of harmful microbes in their finished products compared to levels that may be present in untreated juice.

The second proposed regulation would require warning labels on all packaged juice products that have not been pasteurized or otherwise treated to eliminate harmful microbes.

The required changes in the production process would utilize the Hazard Analysis and Critical Control Point system, or HACCP. HACCP is a scientifically designed program that identifies the steps in food production where contamination is most likely to occur and then puts in place preventive controls. The HACCP system is designed to prevent contaminated food from entering the market. A typical HACCP program imposes specific safety controls and verification requirements on operators of food processing facilities. HACCP programs are already federally required at seafood, meat and poultry processing plants.

The HACCP regulation would apply to juice manufacturers that sell products in the United States. There are two basic types of juice producers: those that treat their products to reduce the risk of contamination with harmful microorganisms, and those that do not. Some 98 percent of juices sold in the United States is pasteurized. Some two percent is not.

The new HACCP regulation is aimed at juice manufacturers who distribute packaged products to consumers. Locations where juice is made and consumed on premises, such as a child's lemonade stand, juice bar, or a restaurant would not be affected.

As part of their HACCP plans, fresh juice processors would be required to have processes in place to reduce the number of harmful microbes to the same level achievable by pasteurization. Juice processors would be free to employ microbial reduction methods other than pasteurization, including washing, scrubbing, anti-microbial solutions, alternative technologies or a combination of techniques.

The proposal comes after the number of consumer illnesses associated with juice products has risen during the past several years, including a 1996 E. coli O157:H7 outbreak associated with apple juice products. That outbreak sickened at least 66 people in the Western United States and Canada, including a child who died from the infection. Foodborne infections are especially dangerous for the very young, the very old and those with weakened immune systems. FDA estimates that there are between 16,000 to 48,000 cases of juice-related illnesses each year.

"Consumers can rely on the safety of most juice products, particularly those that have been pasteurized," said Michael A. Friedman, M.D., Lead Deputy Commissioner of the Food and Drug Administration. "However, an increasing number of consumers have gotten sick from juice products over the years -- usually from untreated juices -- because they were contaminated with a pathogenic microbe. The HACCP program will help protect the juice that American families consume each day."

Consumer illnesses associated with juice products include salmonella infection from orange juice and, more seriously, E. coli O157:H7 infection from unpasteurized apple cider and apple juice products.

Once the HACCP regulation is finalized, implementation would allow a year for large manufacturers, two years for small businesses, and three years for very small businesses.

Given the phase-in periods required to implement the HACCP regulation, a labeling rule has also been proposed. This rule would require manufacturers of juices that are not pasteurized or otherwise treated to kill microbes to put a warning label on containers, advising consumers of the potential risk of consuming untreated products. The label would state: "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria which can cause serious illness in children, the elderly, and persons with weakened immune systems." The labels would be required for all packages of untreated juices. A label would not be required for unpackaged juice sold for immediate consumption such as freshly squeezed juice served at a restaurant.

Warning labels on untreated juice products would ensure that consumers are adequately informed of the risks from consumption. Warning labels would not be required on juice products that are processed under HACCP programs or that are treated to reduce harmful microbes by 100,000 - fold.

Secretary of Health and Human Services Donna Shalala said that the labeling requirement was an important element of the proposal because it warns consumers that unpasteurized products -- or those not otherwise treated to kill harmful microbes -- carry an additional risk of illness.

"We want people to know that juices that are not pasteurized carry a small but nevertheless real added risk that a pathogen could be present," Secretary Shalala said. "These proposed labels will warn consumers that products that are not pasteurized or otherwise treated to kill harmful microbes should not be fed to people most vulnerable to infection -- young children, the elderly, or anyone who has a suppressed immune system from cancer treatment, HIV infection or other significant health problem."

FDA's proposal was developed with input from the public, industry, and the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), an advisory panel of independent experts who provide guidance to FDA and USDA on matters concerning the safety and regulation of foods. In December 1996, FDA convened a two-day public meeting to review the science, technology and manufacturing practices related to the safe production of juices. Following that hearing, the NACMCF concluded that there are safety concerns with juices, especially unpasteurized juices, and recommended that juice processors adopt HACCP programs.

FDA is soliciting comments from the public and industry on its proposals. The full proposal is on display today at the Federal Register Office. Comments may be submitted for the next 75 days on the HACCP proposal and the next 30 days on the labeling proposal to FDA's Dockets Management Branch, HFA-305, Food and Drug Administration, 12410 Parklawn Drive, Room 1-23, Rockville, Md. 20857.

The Administration expects to finalize the labeling provision in time for the apple harvest season this fall.

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